Highlights

• Cynata Therapeutics made great progress in various active clinical trials during the quarter ended 30 June 2022.
• Cynata’s IND application for a Phase 2 trial in acute graft-versus-host disease (aGvHD) was cleared by the US FDA.
• CYP continued to enroll patients actively in three clinical trials - Phase 3 SCUlpTOR trial, MEND trial and DFU clinical trial.
• The company ended the quarter with AU$23.8 million cash.

Leading clinical-stage biotechnology company, Cynata Therapeutics Limited (ASX:CYP), made a progressive leap in the development of therapies based on its proprietary therapeutic stem cell platform technology, Cymerus™ during the June quarter. The latest report released by the company highlights the major milestones achieved during the three-month period ended 30 June 2022.

Here's all about the recent developments in Cynata’s active clinical trials:

• Cynata received clearance from the United States Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for a Phase 2 clinical trial of CYP-001 in patients with high risk aGvHD. It will serve as a gateway for Cynata’s clinical trials for further development and commercialisation in the US.
  
  It is likely that the proposed Phase 2 clinical trial will begin later this year, while the results of the primary evaluation are anticipated in the year 2024. A total of 60 patients will be recruited for the trial.

• Cynata is advancing patient enrolment in the Phase 3 clinical trial in structure-modifying treatment for medial tibiofemoral osteoarthritis. Sponsored by the University of Sydney, the Phase 3 SCUlpTOR trial has been designed to assess the efficacy of CYP-004, as compared to placebo on clinical outcomes and knee joint structure over a period of two years.
  
  It is the largest randomised controlled trial of mesenchymal stem cells (MSCs) conducted in patients with osteoarthritis worldwide, with results having the potential to disrupt clinical management of OA patients.
  
  As of now, there isn’t a cure for osteoarthritis. All the existing options for treating osteoarthritis are limited to managing the symptoms. However, for MSCs, the preclinical research suggests that they may evoke a regenerative response in the underlying disease, which is a prominent unmet need with market size of around US$11.6 billion.

• In the MEND trial, Cynata expects to complete the ongoing patient recruitment and treatment later this year. To scale up the enrolment process in the trial, Cynata has added St George Hospital, the largest hospital in the South Eastern Sydney Local Health District, as its new site.

• Cynata is advancing enrolment of subjects in the Diabetic Foot Ulcers (DFU) clinical trial. The recruited patients are being followed for a four-week treatment period. Every subject will be evaluated for a period of 24 weeks. During the trial, CYP-006TK or a standard treatment will be administered on the enrolled subjects.

Pre-clinical trial update

A pre-clinical study conducted by Cynata in an animal model of n idiopathic pulmonary fibrosis (IPF), a serious lung disease, suggested positive results for the efficacy and molecular mechanisms of action of MSCs. It highlighted that there was a significant reduction in bleomycin-induced pulmonary fibrosis in mice, which mimics IPF in humans, and a high potency anti-inflammatory effect of Cynata’s Cymerus™ MSCs on the airways/lungs.  Moreover, the findings support the implementation of future clinical trials designed to analyse the use of Cymerus™ MSCs in treating fibrotic diseases of the lungs and other organs.

Progressive outlook on clinical trials

Cynata hosts a strong and diverse product pipeline. The versatility of MSCs and Cymerus™ technology form a powerful clinical asset for Cynata. In addition, the positive preclinical and clinical data provide great evidence supporting the use of MSCs for a variety of target indications.

In the coming quarters, Cynata expects to complete recruitment process for many of its trials by the end of this year and initiate the next phase of development in the active clinical trials. Also, there have been positive preclinical data demonstrated in a host of disease models including in IPF, renal transplantation and myocardial infarction (heart attacks).

Cynata continues to remain focused to move ahead on a prospective pathway and associate with potential partners to achieve various commercial goals.